Acquired Rifampicin Resistance has emerged as an important issue in the treatment of HIV-TB patients. It has not been a major problem in HIV-negative individuals treated for TB treated with standard intermittent regimens. The study would generate data on the efficacy of daily and thrice weekly regimen of ATT in pulmonary TB patients with HIV in the presence of highly active antiretroviral therapy (HAART). Not many trials have compared sputum conversion and adverse drug reaction between daily and intermittent regimens of ATT in HIV positive patients. This study provides a unique opportunity for comparison of daily and intermittent therapy for HIV patients with pulmonary TB looking into multiple dimensions of HIV-TB treatment namely efficacy, drug resistance, toxicity , drug interaction and immune reconstitution inflammatory syndrome. The primary outcome of the study is to compare the efficacy of three anti-TB regimens in a) reducing bacteriological failures and b) decreasing the emergence of Acquired Rifampicin Resistance (ARR). The secondary outcomes include unfavourable responses (clinical failures, deaths, relapses) as whole, treatment emergent adverse drug reactions, pharmacokinetic levels of ATT and incidence of immune reconstitution syndrome.

Further study details as provided by Tuberculosis Research Centre, India:

Primary Outcome Measures:

Development of bacteriological failure & Emergence of acquired rifampicin resistance [ Time Frame: At the end of 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Unfavorable responses: clinical failures, recurrences and death due to TB during treatment and follow-up [ Time Frame: At the end of 6 months and at the end of follow-up of 1 year ] [ Designated as safety issue: Yes ]

TEADR's between the groups [ Time Frame: At the end of 6 months and at the end of follow-up of 1 year ] [ Designated as safety issue: Yes ]

Incidence of Immune Reconstitution Syndrome among the groups [ Time Frame: At the end of 6 months and at the end of follow-up of 1 year ] [ Designated as safety issue: Yes ]

Patients on second line ART, mainly protease inhibitors, at initial presentation.

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00933790